[Federal Register: March 5, 2004 (Volume 69, Number 44)]
[Notices]
[Page 10458-10459]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr04-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0137]
Guidance for Industry and Food and Drug Administration Staff;
Surgical Masks--Premarket Notification Submissions; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Surgical Masks--Premarket
Notification [510(k)] Submissions.'' This guidance is intended to
assist industry in preparing premarket notification submissions for
surgical masks.
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Surgical Masks--Premarket
Notification Submissions'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send one self-addressed adhesive labels to
assist that office in processing your request, or fax your request to
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8913.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 15, 2003 (68 FR 26308), FDA
announced the availability of a draft of this guidance document and
invited interested persons to comment by June 16, 2003. FDA received
four comments. The comments suggested various clarifications to the
scope of the devices addressed by the guidance and to testing methods
cited in the guidance, and other minor points. FDA revised the guidance
to clarify these points.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on premarket notification submissions for
surgical masks. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E, OMB control number 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB under OMB control number 0910-
0485.
IV. Electronic Access
To receive ``Surgical Masks--Premarket Notification Submissions''
by fax machine, call the Center for Devices and Radiological Health
(CDRH) Facts-On-Demand system at 800-899-0381, or 301-827-0111 from a
touch-tone telephone. Press 1 to enter the system. At the second voice
prompt, press 1 to order a document. Enter the document number (094)
followed by the pound sign ([numsign]). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters,
[[Page 10459]]
and other device-oriented information. The CDRH Web site may be
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.
guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding the guidance
at any time. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Submit two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Comments received may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 25, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. 04-4982 Filed 3-4-04; 8:45 am]
BILLING CODE 4160-01-S